Trial Outcomes & Findings for Silodosin Versus Tamsulosin for Treatment of Ureteral Stones (NCT NCT02369744)
NCT ID: NCT02369744
Last Updated: 2020-06-23
Results Overview
The primary outcome measure will be the time it takes for the stone to pass. Stone passage will be defined as the subject self-reporting passage of a stone that is consistent with their imaging, or resolution of their pain to suggest unseen passage of their stone. This outcome will be measured from the initial emergency department visit, and gathered at the one-week follow-up call as well as the two-week follow-up visit.
TERMINATED
PHASE4
1 participants
at 2 weeks
2020-06-23
Participant Flow
0 Participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available
0 Participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available
Participant milestones
| Measure |
Silodosin
Subjects in the Silodosin Group will be given silodosin 8 mg tablets, one tablet to be taken PO each day for two weeks.
Silodosin: 8mg tablet, 1 tab PO daily for 2 weeks
|
Tamsulosin
Subjects in the Tamsulosin Group will be given tamsulosin 0.4 mg tablets, one tablet to be taken PO each day for two weeks.
Tamsulosin: 0.4 mg Tab, 1 tab PO daily for 2 weeks
|
|---|---|---|
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Overall Study
STARTED
|
0
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0
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Overall Study
COMPLETED
|
0
|
0
|
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Overall Study
NOT COMPLETED
|
0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Silodosin Versus Tamsulosin for Treatment of Ureteral Stones
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: at 2 weeksPopulation: Data is not available
The primary outcome measure will be the time it takes for the stone to pass. Stone passage will be defined as the subject self-reporting passage of a stone that is consistent with their imaging, or resolution of their pain to suggest unseen passage of their stone. This outcome will be measured from the initial emergency department visit, and gathered at the one-week follow-up call as well as the two-week follow-up visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 2 weeksPopulation: Data is not available
The subject will be given a standardized pain medication prescription at their initial visit, and will be asked to keep track of how much pain medication they used each day, as well as to bring their pill bottle with them to the two-week follow-up appointment for a pill count. This information will be collected at the two-week follow-up appointment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 2 weeksPopulation: Data is not available
Subjects will be given instructions at the initial visit to return to the emergency department immediately for signs and symptoms of infection or MET failure (fever, worsening pain, vomiting, lethargy, unsteadiness, syncope or inability to tolerate oral pain medications). These subjects will be considered to have failed outpatient treatment and will be removed from the study. Subjects who do not experience these issues but who still report having symptoms at the two-week follow-up visit will also be considered to have failed outpatient treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 2 weeksPopulation: Data is not available
Both tamsulosin and silodosin carry the possibility of causing orthostatic hypotension, which can manifest as unsteadiness, syncope, headache, and/or dizziness, especially when changing position from sitting/laying to standing. Subjects will be asked to assess themselves for these symptoms continuously from the initial visit, with serious reactions resulting in cessation of study medication. For reactions which are not serious, the information will be collected at the one-week follow-up call as well as the two-week follow-up visit.
Outcome measures
Outcome data not reported
Adverse Events
Silodosin
Tamsulosin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kamran Mohiuddin; Director ED Clinical Research
Albert Einstein Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place